Roche submits filing to FDA for companion diagnostic for NSCLC drug therapy Roche announced it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval, or PMA, to the FDA, as a companion diagnostic test for AZD9291, an AstraZeneca (AZN) investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation. Patients with non-small cell lung cancer who have adenocarcinoma with tumor containing an EGFR sensitizing mutation show significant benefit from currently available EGFR TKI therapies. However, approximately two-thirds of these patients will relapse and develop drug resistance. In many cases, this resistance is caused by an acquired mutation called T790M. The cobas EGFR v2 test can aid clinicians to appropriately select NSCLC patients who have acquired the T790M mutation and are most likely to benefit from AstraZeneca's novel therapy.

Whole Foods sees 2015 sales growth of 9% Sees 2015 comparable store sales growth in the low single digits. The company said, "In this rapidly changing marketplace, we believe we are taking the necessary steps to position ourselves for the longer term," added Robb. "We remain focused on innovating and evolving to best serve our customers' diverse purchasing preferences. From the unique experience of our Whole Foods Market stores, to our growing online channel for home delivery, to the exciting launch of our 365 by Whole Foods Market stores, we are making investments to extend our reach to both new and existing customers."

Earnings Preview: Whole Foods 'value' concept in focus ahead of earningsWhole Foods Market (WFM) is scheduled to report third quarter earnings after the market close on Wednesday, July 29, with a conference call scheduled for 5:00 pm ET. Whole Foods Market is a retailer of natural and organic foods and grocer, with over 400 stores through the U.S., Canada, and the U.K. EXPECTATIONS: Analysts are expecting earnings per share of 45c on revenue of $3.69B, according to First Call. The consensus range for EPS is 43c-47c on revenue of $3.58B-$3.8B. LAST QUARTER: On May 6, Whole Foods reported second quarter EPS excluding special items of 43c, matching consensus estimates, on revenue of $3.65B, falling just short of analyst expectations of $3.7B. Whole Foods also reported second quarter same store sales growth of 3.6%. The company backed its expectation for fiscal year 2015 same store sales growth in a low to middle single digits percentage range. WHAT'S NOTABLE: During its second quarter earnings conference call, Whole Foods announced that it will launch a lower-cost concept that will offer its "industry-leading quality standards at value prices," geared toward millennial shoppers while appealing to "anyone looking for high-quality fresh food at great prices." The company said at the time it plans to begin opening stores next year and sees a "fairly rapid expansion" from there. On June 11, Whole Foods said the name of its value-focused brand will be "365 by Whole Foods Market," slated to begin opening stores in 2016. On July 1, regarding pricing issues in its New York stores, Whole Foods released a video in which co-CEOs John Mackey and Walter Robb stated, "Straight up, we've made some mistakes. We want to own that, and tell you what we're doing about it... We know [the mistakes are] unintentional because the mistakes are both in the customer's favor, and sometimes not in the customer's favor... We're doing a number of things [to fix this issue]. Most importantly, we're going to increase our training in our New York stores and around the country, because we want to be perfect in this area... Secondly, we're implementing a third-party auditing system so that we can see whether we're making progress in this area or not - and in another 45 days, we're going to begin reporting back to you, the customer, exactly what kind of progress we're making here. The final thing is that we want to give [a] 100% guarantee to our customers. If for any reason you think there's a mistake... if there's a mistake that's not in your favor, we promise to give you that item for free." STREET RESEARCH: On the day after the company's last earnings report, the stock received at least one upgrade and at least one downgrade. RBC Capital upgraded the stock to Outperform from Sector Perform, thinking that its comparable sales can accelerate, driven by easier comparisons and store refreshes. RBC also lowered Whole Foods' price target to $51 from $54. The same day, Bank of America Merrill Lynch downgraded Whole Foods to Neutral and cut its price target on shares to $48 from $65, citing an uncertain same store sales outlook and the potential impact of its new store concept on its core business. Credit Suisse maintained its Neutral rating on the company, but lowered the price target to $40 from $52 due to weaker Q2 comps and the strategy shift to a value-oriented format. Deutsche Bank also lowered its price target for Whole Foods to $40 from $54 for similar reasons. On June 9, Macquarie initiated Whole Foods with a Neutral rating and a $44 price target. On July 13, Cowen said its survey of over 1,000 U.S. consumers regarding their food behaviors indicated that that buyers are in an early stage of demand for more transparent grocery and restaurant offerings. Cowen added in that note that it was concerned about how Whole Foods' rollout of a second concept could potentially impact its core brand. PRICE ACTION: Shares of Whole Foods have slid more than 13.5% over the past three months. In afternoon trading, Whole Foods shares were up 1.6% to $41.60 ahead of the company's earnings report tonight.

Genzyme acquires Caprelsa from AstraZeneca for $300MGenzyme, a Sanofi (SNY) company, announced that it has entered into a definitive agreement with AstraZeneca (AZN) to acquire Caprelsa, a rare disease therapy, indicated for the treatment of symptomatic or progressive medullary thyroid carcinoma in patients with unresectable locally advanced or metastatic disease. Caprelsa is an oral kinase inhibitor treatment and is currently available in 28 countries. Caprelsa is in Phase III development for differentiated thyroid carcinoma, with the study expected to finish in the second half of 2015. Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300M, including an upfront payment of $165M to acquire the global rights to sell and further develop Caprelsa, and further development and sales milestone payments of up to $135M. The transaction does not include the transfer of any AstraZeneca employees or facilities.

Piper cuts Array target by only 50c after failed trialPiper Jaffray analyst Edward Tenthoff says selumetinib for Uveal Melanoma is a small indication and represented only a small part of his valuation for Array BioPharma (ARRY). As such, after partner AstraZeneca (AZN) announced that selumetinib failed in the Phase III trial, the analyst cut his price target for Array by only 50c to $14.50. The primary drivers for Array remain binimetinib and encorafenib in NRAS and BRAF melanoma and low-grade serous ovarian cancer, the analyst tells investors in a research note. He keeps an Overweight rating on the stock.

AstraZeneca says Phase 3 study of selumetinib did not meet primary endpoint AstraZeneca (AZN) announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary Phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase 3 study in differentiated thyroid cancer and in a Phase 2 registration study in patients with neurofibromatosis Type 1. Selumetinib is an oral small molecule MEK inhibitor invented by Array BioPharma (ARRY) and licensed to AstraZeneca in 2003.